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Related Experiment Video

Updated: Jun 20, 2026

Building Up a High-throughput Screening Platform to Assess the Heterogeneity of HER2 Gene Amplification in Breast Cancers

Building Up a High-throughput Screening Platform to Assess the Heterogeneity of HER2 Gene Amplification in Breast Cancers

Published on: December 5, 2017

HER2 testing: evolution and update for a companion diagnostic assay.

Charles J Robbins¹, Katherine M Bates¹, David L Rimm²

¹Department of Pathology, Yale University School of Medicine, New Haven, CT, USA.

Nature Reviews. Clinical Oncology

|April 8, 2025

Summary

Human epidermal growth factor receptor 2 (HER2) testing is crucial for selecting targeted therapies in various cancers. Evolving methods, including quantitative techniques, are essential for accurately assessing HER2 expression, especially for HER2-low tumors, to guide treatment decisions.

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Published on: May 9, 2025

Area of Science:

Oncology
Molecular Diagnostics
Biomarker Analysis

Background:

Human epidermal growth factor receptor 2 (HER2) testing is vital for HER2-targeted therapy selection in breast and other solid cancers.
HER2 assessment has evolved from immunohistochemistry and FISH to quantitative methods.
New antibody-drug conjugates effective at low HER2 levels necessitate re-evaluating HER2 testing, particularly for HER2-low expression.

Purpose of the Study:

To provide an in-depth review of the evolution of HER2 testing methodologies.
To discuss current clinical guidelines and challenges in HER2 testing across solid tumors.
To explore emerging quantitative techniques for improved HER2 assessment.

Main Methods:

Review of historical and current HER2 testing modalities (e.g., IHC, FISH, western blot).
Analysis of clinical guidelines for HER2 testing in various solid tumors.
Evaluation of novel quantitative approaches like immunofluorescence and RNA-based assays.

Main Results:

Significant evolution in HER2 testing methods, driven by new targeted therapies.
Challenges persist with current methodologies, especially in defining HER2-low expression.
Quantitative techniques show promise in overcoming limitations of traditional assays.

Conclusions:

Accurate HER2 testing is critical for guiding treatment strategies and improving patient outcomes.
Emerging quantitative diagnostic approaches are essential for precise HER2 assessment.
Continued advancements in HER2 testing are needed as targeted therapies expand to more tumor types.